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Autologous Regeneration of Tissue (ART) for Wound Healing

Primary Purpose

Wound of Skin

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous Regeneration of Tissue (ART) device
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound of Skin focused on measuring Chronic Wound

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults from 18 to 90 years of age.
  • Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration.
  • Able and willing to give consent for the study.

Exclusion Criteria:

  • Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential).
  • Adults unable to consent.
  • Prisoners.
  • Subjects requiring concurrent systemic antimicrobials during the study period for any infection.
  • Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease.
  • Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents.
  • Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
  • Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days.

Outcomes

Primary Outcome Measures

Change of pain on harvesting of skin at donor site.
Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (worst possible pain)
Time to healing of donor sites
At each weekly visit, the donor site will be assessed for wound area in cm^2

Secondary Outcome Measures

Wound healing of recipient site
At each weekly visit, the recipient area will be assessed for healing area percentage
Histologic evaluation
As measured by tissue samples from biopsy

Full Information

First Posted
January 3, 2019
Last Updated
June 7, 2023
Sponsor
University of Miami
Collaborators
Medline Industries
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1. Study Identification

Unique Protocol Identification Number
NCT03796988
Brief Title
Autologous Regeneration of Tissue (ART) for Wound Healing
Official Title
Autologous Regeneration of Tissue (ART) for Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Medline Industries

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound of Skin
Keywords
Chronic Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days.
Intervention Type
Device
Intervention Name(s)
Autologous Regeneration of Tissue (ART) device
Intervention Description
This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.
Primary Outcome Measure Information:
Title
Change of pain on harvesting of skin at donor site.
Description
Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (worst possible pain)
Time Frame
Baseline, Day 56
Title
Time to healing of donor sites
Description
At each weekly visit, the donor site will be assessed for wound area in cm^2
Time Frame
Up to Day 56
Secondary Outcome Measure Information:
Title
Wound healing of recipient site
Description
At each weekly visit, the recipient area will be assessed for healing area percentage
Time Frame
Up to Day 56
Title
Histologic evaluation
Description
As measured by tissue samples from biopsy
Time Frame
Up to Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults from 18 to 90 years of age. Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration. Able and willing to give consent for the study. Exclusion Criteria: Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential). Adults unable to consent. Prisoners. Subjects requiring concurrent systemic antimicrobials during the study period for any infection. Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease. Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents. Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin). Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Autologous Regeneration of Tissue (ART) for Wound Healing

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